Description

Tramadol Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of a specific impurity in Tramadol hydrochloride active pharmaceutical ingredient (API) and finished drug products. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Impurity 2 in Tramadol API and formulations during method development and validation.
• Quality Control (QC) Testing: Serves as a system suitability standard and an external standard in HPLC, UPLC, or GC analyses to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and control strategies.
• Research and Development (R&D): Used in pharmacokinetic and metabolic studies to understand the impurity's behavior and in the development of robust synthetic pathways to minimize its formation.

Basic Information

Product Name	Tramadol Impurity 2
CAS No.	187219-95-0
Molecular Formula	C16H25NO2
Molecular Weight	263.38 g/mol
Synonyms	1-(3-Methoxyphenyl)-2-[(dimethylamino)methyl]cyclohexan-1-ol; Tramadol Related Compound B; Tramadol EP Impurity B; Tramadol USP Related Compound B; (1R,2R)-rel-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol; U-26232A; Tramadol Metabolite M2 (isomer)
EINECS	Contact for details

Quality Control

Every batch of Tramadol Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.